- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Sep 1, 2023
697312251PG1009GOgrtač za pacijenta, SM+ is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Crown Name Disposable Hygiene Products Fty. Ltd.. Placed on the EU market in Croatia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697312251110278211 packaging level registered — each level carries its own UDI-DI.
06973122511102× 10 unitsBase unit06973122511119× 10 units(01)06973122511102
European Medical Device Nomenclature — the EU product classification assigned to this device.
T0205NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)CN-MF-000008238The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Croatia; available across 1 country total.
Placed on the market in Croatia; per-country availability dates not published.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
697312251SS100D5On the marketOdijelo za osoblje, plavo, vel. XL697312251SS100D5On the marketOdijelo za osoblje, plavo, vel. XXL697312251SS100D5On the marketOgrtač za posjetitelje, vlies697312251IG10073On the marketOgrtač za posjetitelje, vlies697312251IG10073On the marketOperationshue med bindebånd i nakken697312251CP1006YOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.